“乳核散”中药凝胶定向透药治疗乳腺增生性疾病的临床研究

Clinical Investigation of "Ru HE San" Gel Combined with Traditional Chinese Medicine Directional Drug Therapy Instrument in Treating Hyperplastic Disease of Breast

目的:探讨"乳核散"中药凝胶定向透药治疗乳腺增生性疾病的临床疗效。方法:选择68例乳腺增生性疾病患者,随机分为对照组和治疗组各34例,对照组患者予乳腺宁贴外敷治疗,治疗组患者予"乳核散"中药凝胶定向透药治疗,治疗结束后,比较两组患者疗效、乳房疼痛VAS评分、症状积分及乳腺彩超检查情况。结果:治疗组总有效率为97.1%,对照组为76.5%,治疗组优于对照组,差异有统计学意义(P<0.05);治疗2个疗程后,两组患者症状积分、疼痛VAS评分均下降,彩超下两组患者乳腺腺体厚度、低回声数目及低回声截面积均减少,与治疗前比较,差异均有统计学意义(P<0.05);组间比较,治疗组患者症状积分、疼痛VAS评分改善优于对照组,差异均有统计学意义(P<0.05),且彩超下治疗组患者的低回声区截面积、低回声区数目显著低于对照组(P<0.05);两组患者在治疗期间均未出现严重皮肤不良反应及肝肾功能异常。结论:"乳核散"中药凝胶定向透药治疗乳腺增生性疾病有良好的临床疗效,能够缓解乳腺疼痛、缩小肿块体积,且外用安全、不易过敏。

Objective:To investigate the clinical efficacy of new type of "Ru HE San" gel combined with Traditional Chinese Medicine directional drug therapy instrument in breast hyperplastic diseases.Methods:A total of 68 women with mammary hyperplastic disease were divided into the control group (n=34) and the treatment group (n=34) randomly.The control group were treated with "Ru Xian Ning" plaster,and the treatment group were treated with "Ru He San" gel combined with TCM directional drug therapy instrument.We then compared the curative effect,breast VAS score,TCM symptom scores and color ultrasound in the diagnosis of breast disease.Results:The total effective rate was 97.1% in the treatment group and 76.5% in control group, and the treatment group showed higher total effective rate than control group (P<0.05).Compared with pre-treatment, the clinical efficacy score,VAS score,the breast gland thickness,hypoechoic number and hypoechoic area of the two groups under color ultrasound were decreased with significant differences (P<0.05).Compared between the two groups after treatment,the TCM symptom scores,VAS pain score in the treatment group were lower than those in the control group,and the cross section area and number of low echo area in the treatment group were significantly lower than that in the control group (P<0.05).There was no abnormal liver function,renal function or skin adverse reactions in both groups during the treatment.Conclusion:"Ru HE San" gel combined with traditional Chinese medicine directional drug therapy instrument in treating hyperplastic diseases has a good efficacy,which can help minimize breast pain,reduce the mass volume,and it is safe for external use.